A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia

April 10, 2014 updated by: Janssen Pharmaceutical K.K.

A Placebo-Controlled Double Blind Comparative Study of JNS007ER in Patients With Schizophrenia

The purpose of this study is to evaluate the effectiveness and safety of Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) Paliperidone compared to placebo in patients with Schizophrenia. Olanzapine will be used as a reference drug in the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, double blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), placebo- and active-controlled, parallel-group study. Patients will be randomized into 1 of 3 treatment groups to receive oral dosages of Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone 6 mg, olanzapine 10 mg, or placebo. They will receive two capsules of Paliperidone ER 3 mg, placebo or Olanzapine 5 mg once daily after breakfast for 6 weeks. The study will include a screening period, followed by double-blind treatment for 6 weeks.

Study Type

Interventional

Enrollment (Actual)

394

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aizuwakamatsu, Japan
      • Fujioka, Japan
      • Fujisawa, Japan
      • Fukui, Japan
      • Hadano, Japan
      • Himeji, Japan
      • Hiratsuka, Japan
      • Hiroshima, Japan
      • Ibaraki, Japan
      • Ichikawa, Japan
      • Iida, Japan
      • Inazawa, Japan
      • Itoman, Japan
      • Kaizuka, Japan
      • Kanzaki, Japan
      • Kashihara, Japan
      • Kitakyushu, Japan
      • Kochi, Japan
      • Koushi N/A, Japan
      • Kumamoto, Japan
      • Kurayoshi, Japan
      • Matsudo, Japan
      • Matsusaka, Japan
      • Moriguchi, Japan
      • Morioka, Japan
      • Nagoya, Japan
      • Naha, Japan
      • Nakagami, Japan
      • Nankoku, Japan
      • Nishinomiya, Japan
      • Noda, Japan
      • Numazu, Japan
      • Ohta, Japan
      • Oita, Japan
      • Okinawa, Japan
      • Oyama, Japan
      • Sakai, Japan
      • Sapporo, Japan
      • Takasaki, Japan
      • Takatsuki, Japan
      • Tanba, Japan
      • Togane, Japan
      • Tokyo, Japan
      • Tottori, Japan
      • Toyama, Japan
      • Toyoake, Japan
      • Toyonaka, Japan
      • Tsuyama, Japan
      • Ueda, Japan
      • Urasoe, Japan
      • Uruma, Japan
      • Yanagawa, Japan
      • Yao, Japan
      • Yokkaichi, Japan
      • Yokohama, Japan
      • Yokosuka, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who have given their own consent in writing to participate in the study
  • Patients diagnosed with schizophrenia according to the diagnostic criteria of DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 295.30, 295.10, 295.20, 295.90, 295.60)
  • Patients who have acute symptoms of schizophrenia
  • Both inpatients and outpatients are acceptable

Exclusion Criteria:

  • A DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) of a mental disease diagnosis other than schizophrenia
  • A DSM-IV diagnosis of substance-related disorder (except nicotine dependence and caffeine dependence) within 180 days before the screening test
  • Total PANSS (Positive and Negative Syndrome System) score at the screening test <70 or >120
  • Patients treated with three or more types of antipsychotic within 28 days before the screening test
  • Parkinson's disease (except for those with drug-induced extra pyramidal symptoms)
  • Patients with a complication of or a past history of cerebrovascular accident
  • Patients with a complication of or a past history of diabetes mellitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Form= tablet, route= oral use. Two tablets once daily for 6 weeks.
Active Comparator: Olanzapine
Drug: Olanzapine
Type= exact number, unit= mg, number= 2.5, form= tablet, route= oral use. Four tablets once daily for 6 weeks.
Experimental: ER OROS paliperidone
Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone
Drug: ER OROS paliperidone
Type= exact number, unit= mg, number= 3, form= tablet, route= oral use. Two tablets once daily for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Total Positive and Negative Syndrome Scale (PANSS).
Time Frame: Baseline and 6 weeks
PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).
Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score
Time Frame: Baseline and 6 weeks
The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
Baseline and 6 weeks
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score
Time Frame: Baseline and 6 weeks
The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
Baseline and 6 weeks
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score
Time Frame: Baseline and 6 weeks
The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).
Baseline and 6 weeks
Proportion of Responders (≥30% Decrease in Total Positive and Negative Syndrome Scale [PANSS])
Time Frame: Baseline and 6 weeks
Responders are subjects with 30% or more reduction from baseline in total PANSS score. PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).
Baseline and 6 weeks
Change From Baseline in Clinical Global Impression Scale (CGI-S)
Time Frame: Baseline and 6 weeks
The CGI-S rating scale is a 7-point global assessment with scores as follows: 1 - Not ill, 2 - Very Mild, 3 - Mild, 4 - Moderate, 5 - Marked, 6 - Severe, and 7 - Extremely Severe.
Baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Pharmaceutical K.K.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

November 3, 2006

First Submitted That Met QC Criteria

November 3, 2006

First Posted (Estimate)

November 7, 2006

Study Record Updates

Last Update Posted (Estimate)

April 29, 2014

Last Update Submitted That Met QC Criteria

April 10, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR012625
  • JNS007ER-JPN-S31 (Other Identifier: Janssen Pharmaceutical K.K., Japan)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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